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Clinical Practice Guidelines

DEAR SIR,

I am writing to you regarding the‘Summary of guideline for the treat-ment of bipolar disorder’, publishedin your March 2003 issue,

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which isin general an excellent paper. How-ever, it does not take into account therealities of everyday private practice.

For example, the drug Lamotrigine isrecommended on a number of occa-sions throughout the article: on p. 49as a mood stabilizer in bipolar depres-sion, on p. 51 as a second choice forrapid cycling and first choice fornon-rapid cycling. Even though thismedication has significant publishedliterature to support these recom-mendations, it is not currently avail-able in Australia for the indicationsoutlined and under the Pharma-ceutical Benefits Scheme (PBS) it isapproved for use only in ‘epilepticseizures not controlled by other anti-epileptic drugs’; its only use both onand off the PBS is in ‘partial andgeneralized seizures in adults andchildren’. I raise this point because,after reading the summary of treat-ment guidelines and having read thevery similar American equivalent,I contacted the drug company thatmarkets Lamotrigine (known as Lam-ictal in Australia), Glaxo, Smith Klineand I was told that this drug is cur-rently not indicated for use in mooddisorders in Australia and, further-more, that the company is notcurrently marketing the drug to psy-chiatrists in Australia. I was toldin no uncertain terms that untilapproval was granted by the Thera-peutic Goods Administration forthose indications, I would be usingthe drug against the company’swishes and at my own risk.

Perhaps one of the problems withexpert committees is that they do nothave on them anyone in everydayprivate practice. I noticed that theRoyal Australian and New ZealandCollege of Psychiatrists ClinicalPractice Guideline Team for Bipolar

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Disorder included a professor of psy-chiatry, a senior lecturer at the schoolof psychiatry, a research officer, anda research psychologist. In fact, morethan half of the College members arein private practice where recommen-dations like these are unable to beused; unfortunately, we are muchmore open to the dangers of litiga-tion than persons protected by largeinstitutions.

I hope this letter can be taken asconstructive criticism and perhaps, infuture, the non-approved status of adrug can be highlighted, even with acautionary note about off-label usage.

REFERENCE

1.

Mitchell PB, Malhi GS, Redwood BL, Ball J for theRANZCP Clinical Practice Guideline Team for BipolarDisorder. Summary of guideline for the treatment ofbipolar disorder.

Australasian Psychiatry

2003;

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:39–53.

Kevin McNamara

Currumbin Qld